Rett SyndromeNCT05352373
The Role of Dietary Calcium for the Treatment of Osteopenia in Girls With Rett Syndrome
A study testing calcium in people with Rett Syndrome, run by Baylor College of Medicine.
Trial summary
Randomized, placebo-controlled trial of oral calcium supplementation for osteopenia in girls and women with Rett syndrome Read more about this study
- Who is it for?
- Ages 5 to 30 years, women only
- Conditions the study is for
- Rett Syndrome
- What is being tested?
- calcium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2008to 1 Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 30 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- clinical diagnosis of Rett syndrome
Who cannot join
- parathyroid disease
- renal disease
About this study
Randomized, placebo-controlled trial of oral calcium supplementation for osteopenia in girls and women with Rett syndrome
Read the detailed description
Objective: The investigators conducted a randomized, double-blind, placebo-controlled trial to determine the safety and efficacy of oral calcium supplementation for the treatment of bone mineral deficits in individuals with Rett syndrome (RTT).
Methods: The investigators measured total body bone mineral content (BMC) and bone mineral density (BMD) by dual-energy x-ray absorptiometry and biomarkers of bone turnover by clinical laboratory techniques before and one year after oral calcium or placebo supplementation in 32 pre- and post-pubertal girls and young women with RTT. The calcium supplement was calculated to provide a twofold increase in the recommended dietary allowance of calcium for age.
- Conditions
- Rett Syndrome
- Being tested
- calcium, placebo
- Keywords
- Low bone mass
- Medical subject headings
- Rett Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calciumDietary supplement
calcium carbonate
placeboDietary supplement
sodium bicarbonate
| Study group | Role | What they receive |
|---|---|---|
| Rett Active Supplement | Active comparator | Females with clinical diagnosis of Rett syndrome treated orally daily with calcium carbonate, dose based on Dietary Reference Intake for age, for one year Receives: Dietary Supplement: calcium |
| Rett Placebo Supplement | Placebo comparator | Females with clinical diagnosis of Rett syndrome treated orally daily with sodium bicarbonate, dose based on equivalent weight for active supplement for age, for one year Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral content (BMC)
Bone mineral content (z-score) measured by dual-energy x-ray absorptiometry
Measured: change from baseline to 1 year thereafter
Bone mineral density (BMD)
Bone mineral density (z-score) measured by dual-energy x-ray absorptiometry
Measured: change from baseline to 1 year thereafter
Secondary outcomes (4)
Osteocalcin
Serum Osteocalcin (ng/ml)
Measured: change from baseline to 1 year thereafter
Bone alkaline phosphatase
Serum Bone alkaline phosphatase (mcg/ml)
Measured: change from baseline to 1 year thereafter
C-telopeptide
Serum C-telopeptide (pg/ml)
Measured: change from baseline to 1 year thereafter
Calcium/creatinine ratio
Urinary calcium/creatinine ratio (mg/g)
Measured: change from baseline to 1 year thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start1 Mar 2008
- Primary completion1 Mar 2012
- Study completion1 Mar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rett SyndromeStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double blind
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathleen J Motil, Baylor College of Medicine
- Investigators
- Kathleen J Motil, MD, PHD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352373
- Sponsor's protocol ID
- H-19205
- Status last verified
- Apr 2022
- First submitted
- 15 Apr 2022
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Dietary Calcium for the Treatment of Osteopenia in Girls With Rett Syndrome
- ClinicalTrials.gov ID
- NCT05352373
- Acronym / sponsor ID
- H-19205
- Conditions
- Rett Syndrome
- Keywords
- Low bone mass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2008 (actual)
- Primary completion
- 1 Mar 2012 (actual)
- Study completion
- 1 Mar 2012 (actual)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, placebo-controlled trial of oral calcium supplementation for osteopenia in girls and women with Rett syndrome
Detailed description
Objective: The investigators conducted a randomized, double-blind, placebo-controlled trial to determine the safety and efficacy of oral calcium supplementation for the treatment of bone mineral deficits in individuals with Rett syndrome (RTT).
Methods: The investigators measured total body bone mineral content (BMC) and bone mineral density (BMD) by dual-energy x-ray absorptiometry and biomarkers of bone turnover by clinical laboratory techniques before and one year after oral calcium or placebo supplementation in 32 pre- and post-pubertal girls and young women with RTT. The calcium supplement was calculated to provide a twofold increase in the recommended dietary allowance of calcium for age.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- randomized, double blind
| Arm | Type | Receives |
|---|---|---|
| Rett Active Supplement | Active comparator | Dietary Supplement: calciumFemales with clinical diagnosis of Rett syndrome treated orally daily with calcium carbonate, dose based on Dietary Reference Intake for age, for one year |
| Rett Placebo Supplement | Placebo comparator | Dietary Supplement: placeboFemales with clinical diagnosis of Rett syndrome treated orally daily with sodium bicarbonate, dose based on equivalent weight for active supplement for age, for one year |
Who may qualify
- Ages
- 5 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- clinical diagnosis of Rett syndrome
Key exclusion criteria (2 listed)
- parathyroid disease
- renal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| calciumcalcium carbonate | Dietary supplement | Rett Active Supplement |
| placebosodium bicarbonate | Dietary supplement | Rett Placebo Supplement |
Primary outcome
Bone mineral content (BMC)
Time frame: change from baseline to 1 year thereafter
Bone mineral content (z-score) measured by dual-energy x-ray absorptiometry
Bone mineral density (BMD)
Time frame: change from baseline to 1 year thereafter
Bone mineral density (z-score) measured by dual-energy x-ray absorptiometry
4 secondary outcomes
Osteocalcin
Time frame: change from baseline to 1 year thereafter
Bone alkaline phosphatase
Time frame: change from baseline to 1 year thereafter
C-telopeptide
Time frame: change from baseline to 1 year thereafter
Calcium/creatinine ratio
Time frame: change from baseline to 1 year thereafter
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen J Motil, MD, PHD principal investigator
Baylor College of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing calcium in people with Rett Syndrome, run by Baylor College of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral content (BMC) (time frame: change from baseline to 1 year thereafter). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.